Irma Villarreal

PO Box 762034
San Antonio, Texas 78245
210 677 0718
805 750 4527
irmav8@yahoo.com

Executive Summary
• Demonstrate advanced leadership and project management skills in directing large programs and
complex validation projects that entailed an implementation and phased rollout of enterprise
technologies in a matrix environment.
• Provide schedule development, project plan development, quality planning, organizational planning,
staff acquisition, communications planning, risk identification and management, qualitative and
quantitative risk analysis and recommendations.
• Follow and practice all personal and Quality Management System practices to insure that FDA, ISO
and European Medical Device quality standards and regulations are met where applicable.
• Orchestrate improvement project management processes for research and development validation
templates.
• Gather and assemble information from the systems users to develop project/program specification,
test plans, and prepare project documentation.
• Collaborate with cross-functional teams in assessing education/research needs and develop
education/research strategies to meet those needs.
• Empower, educate, and serve as the driving force for orchestrating LIMS implementations that
distinguish credible health information from information that is not trustworthy
• Proven ability to interpret and use project metrics to effectively manage assigned projects.
• Spanish & English Bilingual

Technical Accomplishments
• Guide the development and validation of new analytical methods and the implementation of
compendial methods.
• Provide validation support for LabWare's architecture in the implementation of bi-directional
interface to the Perkin Elmer Waters based spectrophotometers using the integrated LabStation
module. Integrate Lab Ware LIMS in a highly regulated environment to ensure compliance with all
GLP requirements by providing full sample tracking, instrument and calibration management,
and reagents management, full internal auditing, CFR21 Part 11, report and sample scheduling,
and bar coding functions standards
• Manage a group of people in order to maximize their ability and contribution to deliver high quality
projects and studies
• Provide continuity of line management to approximately ten direct reports who are
employed on a project basis, liaising with the study and project management as necessary.
• Ensure that the overall performance of the individuals is proactively managed and they are
trained and developed in order to maximize their contribution.
• Ensure that staff communication and employee relations are managed proactively and
regularly to maximize the motivation and well being of the employees
• Ensure that employees are trained, developed and coached so that their capabilities comply
with Company and regulatory standards and to maximize their contribution to the projects
they are involved in.
• Prepare and update validation SOPs and qualification protocols (IQs, OQs, and PQs) for
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 streamlining validation implementation.
• Review document control changes to products, process, software and other changes for
reliability/quality impact.
• Lead in the implementation of quality systems, process controls and corrective action systems to meet
FDA QSR, MDD and ISO 13485:2003 requirements to ensure safe and effective products are
developed and produced.
• Track open Corrective Action Request (CAPA) and follow-up to ensure that the corrective and
preventive actions are appropriate and effective.
• Identify non-conforming trends, prepare Quality metrics periodic reports and develop investigation
plans if applicable.
• Develop validation needs and strategic plans for on-going continuous improvement. This included the
use of a systematic approach to validations with templates, determining process capability, process
analysis, identifying recommendations for continuous improvement with link to Corrective and
Preventive Action system.
• Develop of Master Validation Plans and ensuring that the plan requirements are fulfilled including
timelines.
• Experience with Six Sigma (DMAIC) in evaluating sample tracking, results handling and process
improvements for Blood Bank industry and CRO sample handling, CEMS for temperature monitoring
• As a laboratory information systems manager, I formulated and defined system scope and
objectives based on end user needs and a thorough understanding of clinical information
systems.
• Orchestrate projects with moderate to large budgets or of an immediate to long duration. Oversee the
projects from original concept through final implementation and provided post- implementation
consultation as needed. Devise or modified procedures to solve complex problems, considering
workflow needs and computer/technology capabilities and/or limitations. Analyze business needs,
prepared documentation of requirements and their translation into proper system requirement
specifications. Instructed, directed and checked the work of system analysis team members.
Responsible for all aspects of the development, which included working with system programmers to
identify areas that required modification to achieve overall efficiency. Perform HPLC analyses at
client site during instrument installation

• Develop detailed work plans, schedules, project estimates, resource plans and status reports.
Conducted project meetings and was responsible for project tracking and analysis. Ensure adherence
to quality standards and reviewed project deliverables. Manage the integration of vendor tasks and
reviewed vendor deliverables and costs. Control costs and maximized productivity through
implementation of effective methods and standard processes. Application of facilitation skills, which
enabled me to resolve conflict among groups, engaged in continuous improvement activities. Proven
ability to lead large development programs and complex projects with large scope across an enterprise.
• Orchestrate selection of contract laboratories for supplemental testing, which had a proven
record of the highest integrity, an implemented continuous improvement quality system in
place and had successfully passed external audits. Their selection was based on their
knowledge of viral testing and prior FDA audit performance. These contract facilities were
held to the highest regulatory standards through thorough continuous evaluation by our
internal quality team.

• Instruct both in classroom and on-line environments for Health Information/Informatics and
Medical Assisting curriculums concurrently. Instruction in microbiology, medical office
procedures and pathophysiology included aseptic technique theory and practice.
Provide unbiased medical information, teaching students how to prepare for physician
visits, and help them to consider their personal values and preferences in making medical
decisions. Understanding medical issues can provide individuals an opportunity to engage in
more effective dialogs with their physicians and take a more active role in the management

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 of their healthcare. I assist students gain the knowledge and motivation they need to become
more meaningful participants in the health care team.

Professional Experience

SQA Services, Inc – Rolling Hills, Cal Jul 06 –Present

Sr.Certified Quality Auditor
• Perform audits for multiple third party pharmaceutical-manufacturing suppliers.

Amgen, Inc – Thousand Oaks, CA Nov’ 05 – Jul 06

Sr. Manager – Biological Sample Management

• Direct overall management and operation of receipt and handling of biological samples for Amgen
global pre clinical and clinical trials including oversight of data management strategies
• Responsible for the management of activities such as preparation of study protocols, informed
consents, study related forms, Case Report Forms (CRFs), regulatory documents, monthly study
progress reports and updates of study specific AE/ or SAE reports.
• Manage flexible resources and grow staff along with the project development for mega studies
• Manage team of thirty-one including Project Specialists, Product Associates and Associate Managers
• Align and collaborate with Project Management, CROs, Research Informatics and Information
Technology Directors to oversee FDA Compliance, Training, Subject Matter Experts and Project
deliverables
• Work cross functionally with study teams, principal investigators, clinical sites and regulatory
peers
• DMAIC to improve sample processing, use of CMMI
• Liaise with CROs for clinical trial testing and FDA compliance
Alcon Laboratories – Ft. Worth, TX Dec ‘03 – Nov ‘05
R&D Validation Specialist /PKDM Department (contract position)

• 21 CFR Part 11, SDLC, OQ, IQ and PQ validations, Process validation of Empower and Labware
LIMS
• Computer software validation, Instrument validation, IQ/OQ/PQ, process validation
• CGMP, GMP, SOP generation, Process change, ISO 9000
• Maintained electronic documentation

Abbott Laboratories – Irving, TX Mar ‘03 – Dec ‘03

Validation Specialist (contract position)

• 21 CFR Part 11, SDLC, OQ, IQ and PQ

• Process validation, Audits, Root Cause Analysis
• CGMP, ISO 9000
• Maintain electronic documentation
• Review pharmaceutical operations, cGMPs, GLPs
• Write and executed validation protocols for the Reliability Group in the Advanced Engineering
Division; Acquired working knowledge of in-house quality systems, 21 CFR Part 11 Compliance,
SDLC, FDA, CAPA, and ISO 9000, design of documents, requirement specifications, unit test
plans, and quality procedures

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 • Perform Installation Qualifications, Operational Qualifications, and Performance Qualifications
for software application for Abbott chemistry analyzers; Wrote software-user guides, and
validated work plans as needed; documented and maintained instrument activity logs.

Mediware Information Systems – Dallas, TX Jan ‘98 – Mar ‘03

Business Analyst

• Maintain department of 6 focus on goals and objectives of assigned initiatives including such
factors as revenue, cost, internal/external impact, timing, issues tracking, resource, and risk
management.
• Manage the software product line life cycle team of subject matter experts from strategic
planning to tactical activities. Liaison between users, customers, and stakeholders and systems
supported by Information Technology for all Patient Services customer’s nationwide facilities.
• Maintain project costs within defined budgeted guidelines; track and report progress as part of
regular status reporting. Direct internal resources, contractors, and external vendors on assigned
projects.
• Perform static and dynamic analysis of LIMS software to discover vulnerabilities and to
improve information security
• Prepare FDA 510 K submissions for software enhancements
• Lead project team regulatory efforts to facilitate early approvals and implementation of
approved plans
• Orchestrate Quality endeavors with programmers to resolve software issues and documented
all activities to be in compliance with FDA regulations
• Contribute to 510k FDA submissions
• Perform audits, Root Cause Analysis, CAPA, continuous improvement strategies
• Lead for driving implementation of a new data management system and its upgrades
• Adhere to current Good Clinical Practices, GMP, HIPAA, and FDA regulations
• Serve as liaison between Company, client, and other outside and in-house project team
members

Blood System Laboratories – Dallas, TX Sep ‘94 – Jan ‘98

Technical Director/Viral Marker

• Implement managed and validated Biological Data Management Systems ensuring adherence
to all regulations and applied compliance processes as required
• Lead and managed teams of 15-20 staff in large central and distributed applications
development, implementation and support.
• Consistently demonstrated application of structured project management methodology to a
staff of 15-20
• Provide change control for scope revisions. Resolve resource conflicts and constraints.
• Create, maintain, and regularly communicate to project team members the project plan and its
progress including: Tasks, Task assignments, Timelines, Milestones and outstanding data
management issues.
• Six Sigma to improve sample and results tracking
Provide regular status reporting. Conduct post-implementation review, comparing objectives to
results.
• Validate LIMS for maintaining laboratory and instrument software compatibility
• Implement and validated LIMS required configuration changes and coordinated required
system upgrades with technical IT staff.
• Write SOPs as well as test and deployment plans for system configuration changes and
upgrades.
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 • Responsible for training personnel in various functions and roles required in the LIMS.
• Work with complicated FDA issues and ISO 9000
• Implement and validated blood bank software
• Implement procedures and policies, improving turn-around time and customer satisfaction
• Conduct internal and third party audits and Root Cause Analyses
• Extensive knowledge and understanding of FDA regulatory requirements (CGMPs, GCMPs,
and Code of Federal Register)
• Demonstrate quality interpersonal and decision-making skills
• Exercise sound judgment in establishing, performing and evaluating laboratory testing

Antrim Corporation – Dallas, TX Aug ‘91 – Sep ‘94

Implementation Analyst

• Empower, educate, and serve as the driving force for orchestrating LIMS implementations
that distinguished credible health information from information that is not trustworthy
• Provide software product management for a staff of 6 in managing full life cycle
information systems projects on large scale systems development for information technology
initiatives
• Achieve consensus within project team on project objectives and scope. Provide leadership,
guidance and adherence to the corporate IT project management and software development
life cycle on new or enhanced product initiatives

• Build department specific implementation dictionaries and tables for handling data
management strategies
• Work with Crystal Reports and ODBC ad hoc writer processes
• Provide laboratory software customer training as well as telephone customer support
• Identify resources and worked with respective AS400 and UNIX programmers

Bio-Rad Laboratories – Hercules, CA Oct ‘89 – Aug ‘91

Diagnostic System Specialist

• Execute Linearity, Precision, Calibration Stability studies

• Provide on site customer training in aseptic techniques including the preparation of solutions
that are free of contamination (particles, bacteria, extraneous material) and ensuring compounding
materials are checked for expiration date, outer integrity, and lot number.
• Provide instruction on preparing the correct compound, dose, and concentration, including
using the appropriate syringe size to measure out fluid volumes in order to minimize errors.
• Implement timeline management, with support of project team members
• Provide on-site customer training
• Provide telephone Diagnostics
• Install hemoglobin HPLC analysis instrumentation and provided on-site customer training
• Perform correlation, precision, and linearity studies as part of the initial installation
Education

• M.A. Medicine – Stanford University School of Medicine, Palo Alto, California

• B.S. Microbiology – University of Texas at San Antonio, San Antonio, Texas
• A.A. Translation – San Antonio College, San Antonio, Texas
• A.S. Biology – San Antonio College, San Antonio, Texas